[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-hodgkins-disease-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-hodgkins-disease-adult":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100465906","phase-2-isatuximab-during-stem-cell-collection-and-transplant-in-patients-with-multiple-myeloma-and-lymphoma-100465906",false,"NCT05346809","Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma","Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Following diagnoses are eligible for inclusion in the study:\n\n   A) Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse.\n\n   B) Relapsed\u002FRefractory Hodgkin's disease\n\n   C) Non-Hodgkin's Lymphomas as follows\n   * Relapsed\u002FRefractory Diffuse large B cell lymphoma\n   * Relapsed\u002FRefractory indolent or relapsed\u002Frefractory transformed indolent B cell lymphomas as consolidation after second line therapy\n   * Mantle Cell lymphoma as consolidation after first-line therapy\n   * Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse or primary refractory disease\n2. Patients undergoing first ASCT will be eligible for the study.\n3. Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed.\n4. Age ≥18 years\n5. Life expectancy of greater than 6 months.\n\nExclusion Criteria:\n\n1. Previously exposure to a CD38 antibody during the last 12 months.\n2. Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks.\n3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.\n4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n5. Pregnant and Lactating women\n6. HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.",[26,27,28,29],"Lymphoma","Multiple Myeloma","Non-Hodgkin Lymphoma","Relapsed Hodgkin's Disease, Adult",[31],"Stem cell transplant","RECRUITING","2025-06-04",{"date":35,"type":36},"2025-06-08","ACTUAL",{"date":38,"type":36},"2023-03-31",{"date":40,"type":20},"2026-09",{"name":42,"class":43},"Divaya Bhutani","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100485006","phase-2-treatment-strategy-for-relapsedrefractory-hodgkin-lymphoma-100485006","NCT05595447","Treatment Strategy for Relapsed\u002FRefractory Hodgkin Lymphoma","Rescue With Brentuximab Plus PD-1 Blockade Followed by Autotransplantation and Consolidation With Brentuximab Plus PD-1 Blockade in Patients With Relapsed\u002FRefractory Hodgkin Lymphoma: Exploratory Single-arm Analysis","Inclusion Criteria:\n\n1. Relapsed\u002Frefractory Hodgkin lymphoma to ABVD with definition of high risk.\n2. Age ≥ 18 years and ≤ 90 years.\n3. Adequate liver function, defined as:\n\n   * Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)\n   * Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN\n   * Serum alanine aminotransferase (ALT) ≤ 3.0 x ULN\n4. Adequate renal functions, defined as:\n\n   • Serum creatinine ≤ 1.5x ULN or glomerular filtration rate \\> 50ml\u002Fmin.\n5. ECOG performance status ≤ 3\n6. Women of reproductive potential should have a serum pregnancy test or negative urine.\n7. Prior signature of the informed consent.\n\nExclusion Criteria:\n\n1. Voluntary withdrawal from the study.\n2. Develop grade 3 or 4 toxicity according to the INH scale.\n3. Loss of follow-up",true,"15 Years","90 Years",{"count":55,"type":20},20,[23,57],"PHASE3","The choice of the best second-line therapy in patients with high LH R\u002FR risk, it is a niche of knowledge not covered at the moment, especially the role of Brentuximab (BV) plus PD-1 blockade and auto-HSCT.\n\nWhat is the progression-free survival and rate of metabolic responses complete in patients with high-risk R\u002FR HL with the treatment strategy: BV+ PD-1 blockade consolidation with Auto-HSCT and maintenance with BV + PD-blockade\n\n1?",[60,61,29],"Hodgkin Lymphoma","Refractory Hodgkin Lymphoma",[63,64,65],"refractory","relapsed","hodgkin lymphoma","2025-03-10",{"date":68,"type":36},"2025-03-12",{"date":70,"type":36},"2022-10-18",{"date":72,"type":20},"2025-10-18",{"name":74,"class":43},"Hospital Regional de Alta Especialidad del Bajio",1]